Genomic Outcomes of Metformin (GOMET)
Coronary Artery Disease, Mild Cognitive Impairment, Obesity, Abdominal
About this trial
This is an interventional health services research trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Age 65 - 79
Must meet criteria from one or more of the following groups:
Group 1 (Can have 1 or 2 of these, but not all 3)
- History of coronary artery disease (MI/heart attack, stroke, heart failure, or peripheral artery disease)
- Cancer, with no active treatment in the last year
- MCI (MoCA >18<26 -inclusive of 1 point if <12 years of education Group 2
- Decline physical function (walking speed < 1 m/s) Group 3 (Either or both)
- Abdominal obesity (>88cm women, >102cm men) AND hypertension (treated or resting blood pressure >140/90
- Abdominal obesity (>88cm women, >102cm men) AND hyperlipidemia (treated or fasting total cholesterol >240 English literacy Willing to provide informed consent
Exclusion Criteria:
- eGFR <45
- Type 2 diabetes (HbA1c>6.5) or type 1 diabetes
- Any tobacco or nicotine product use in the past year
- Low vitamin B12 Levels (< 300 pg/mL)
- Self-reported severe difficulty or inability to walk 400m or climb 10 steps (from Q 2 and 19 on PAT-D)
- Self-reported difficulty or inability to perform basic ADL functions (from Q 10, 13, 14, 16 on PAT-D)
- Excessive alcohol use (>14 drinks/week)
- Cancer requiring treatment in past year (except skin)
- Dementia - diagnosed and/or MoCA score <18
- Parkinson's or other neurological disease
- Chronic liver disease or cirrhosis
- End stage renal disease or on dialysis
- Rheumatic conditions (Rheumatoid arthritis, lupus, and any other autoimmune disease the -PI deems them to be ineligible for)
- Thyroid problems the PI deems them to be ineligible for
- Gout
- Involved in another interventional study
- Hemoglobin <8 or diagnosed with anemia
- Recent unintentional weight change (+/- 10 lbs. in the last 12 months)
- BMI <18.5
- Likely to not follow the protocol
- PI deems unfit to participate
- Already taking Metformin or any other drug intended to treat diabetes
Sites / Locations
- Wake Forest Health Sciences
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Metformin then Placebo
Placebo then Metormin
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm.